510(k) · Cleared
ClearedResusci Flow; Resusci Flow 104
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atom Medical Corporation · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on Apr 6, 2011 as substantially equivalent to K892885 (Fisher & Paykel Electronics, Ltd., 1989) and 1 other predicate after a 215-day review. Its family tree reaches back 3 generations to 1976. 1 of the 9 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 6, 2011
- Review
- 215 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K760102 (1976). 8 ancestors in all. No later device cites it as a predicate yet. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK760102 Flowmeter, P.C., Redesigned VersionOhio Medical Products · 1976
- 2 generations backK971243 Ohmeda Infant Resuscitation SystemOhmeda Medical · 1997
- 1 generation backK070210 Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 2007 · Recalled (Class I)
- This deviceK102542 Resusci Flow; Resusci Flow 104Atom Medical Corporation · 2011
Class I recalls in this family
- K070210 Giraffe and Panda T- Piece Resuscitation Systemdirect predicate · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K760102 | Flowmeter, P.C., Redesigned Version | Ohio Medical Products | 1976 | — |
| −2 | K971243 | Ohmeda Infant Resuscitation System | Ohmeda Medical | 1997 | — |
| −1 | K070210 | Giraffe and Panda T- Piece Resuscitation System | Ohmeda Medical | 2007 | Class I |
| 0 (this device) | K102542 | Resusci Flow; Resusci Flow 104 | Atom Medical Corporation | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 2000 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BTL device
- #1 K242769 VentStar Resus heated (N) (MP17030); VentStar…score 11.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K892885 | Resubmitted RD1000 Neopuff Infant ResuscitatorSummary page 1…Resusci Flow 104 PV Predicate Devices: GE - Giraffe and Panda - K0702 10 Fisher & Paykel - NeoPuff - K892885 Device Description: There are four (4) models of the Resusci Flow resuscitator. * Resusci Flow * Resusci Flow with blender… | 1989 |
| * | K070210 | Giraffe and Panda T- Piece Resuscitation SystemSummary page 1…w and blender Resusci Flow 104 EV Resusci Flow 104 PV Predicate Devices: GE - Giraffe and Panda - K0702 10 Fisher & Paykel - NeoPuff - K892885 Device Description: There are four (4) models of the Resusci F… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K070210Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 2007 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 35 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- 2 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
- 11 other devices also cite its predicate K892885.
How does its category compare?
All BTL devicesBTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · BTL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTL
203in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTL
2in 2024
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · BTL
165in 2025
MAUDE reports naming product code BTL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 122 | 1 | 5 |
| 2008 | 4 | 198 | 0 | 37 |
| 2009 | 5 | 173 | 0 | 69 |
| 2010 | 3 | 140 | 0 | 96 |
| 2011 | 2 | — | 1 | 75 |
| 2012 | 0 | — | 2 (2) | 115 |
| 2013 | 1 | — | 3 (1) | 103 |
| 2014 | 7 | 203 | 0 | 70 |
| 2015 | 1 | — | 3 (2) | 79 |
| 2016 | 0 | — | 0 | 80 |
| 2017 | 2 | — | 0 | 101 |
| 2018 | 1 | — | 0 | 197 |
| 2019 | 1 | — | 3 (3) | 341 |
| 2020 | 1 | — | 0 | 454 |
| 2021 | 1 | — | 1 | 506 |
| 2022 | 0 | — | 0 | 755 |
| 2023 | 1 | — | 0 | 731 |
| 2024 | 0 | — | 2 (2) | 667 |
| 2025 | 1 | — | 0 | 165 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Resusci Flow series (Resusci Flow and Resusci Flow with blender) is a manually operated ventilator intended to assist a doctor in resuscitating an infant who has spontaneous breathing by providing the positive end-expiratory pressure (PEEP) and the peak inspiratory pressure (PIP).
The Resusci Flow series (Resusci Flow 104 PV and Resusci Flow 104EV) is intended for resuscitation of neonates in a delivery room and a NICU. It is used to remove secretions from the neonatal mouth and nostrils or to ventilate or assist in ventilating neonates suffering from apnea or other respiratory failure.
All are intended for neonates and infants (< 10kg or 22 Ibs) in a delivery room and a NICU.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102542: Resusci Flow; Resusci Flow 104.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102542
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026